A milestone has been reached for GRAND PHARMA's key nuclear medicine product, SIR-Spheres® Yttrium-90 (Y90) Microsphere Injection (YIGANTAI®). On April 13, the company announced that its US clinical study (DOORwaY90) evaluating the injection for the treatment of unresectable hepatocellular carcinoma (HCC) has successfully met its preset clinical endpoints, yielding outstanding data. The impressive results not only indicate that the SIR-Spheres personalized dosimetry treatment model surpasses traditional regimens but also expand the application of liver-directed therapy for patients with unresectable HCC, highlighting the product's strong efficacy and market potential. This is expected to further accelerate the sustained rapid sales growth of GRAND PHARMA's Y90 microsphere injection in global markets through the company's own sales network.
Notably, based on breakthrough interim data from the DOORwaY90 trial, the US FDA had already granted formal approval for the Y90 microsphere injection for the unresectable HCC indication, making it the first and only selective internal radiotherapy product globally approved by the FDA for both unresectable HCC and colorectal cancer liver metastases. The successful achievement of the DOORwaY90 study's endpoints provides robust clinical evidence supporting Y90 radioembolization as an effective and liver-protective definitive treatment for unresectable HCC. The clinical data will also strongly support the expansion of the product's indications in China. Furthermore, this outcome demonstrates GRAND PHARMA's strong capabilities in overseas clinical registration, laying an important foundation for the future development and registration of its self-developed innovative nuclear medicines abroad.
The clinical data is highly encouraging, and the expansion of indications is set to strategically enlarge the product's market potential. According to the announcement, the Y90 microsphere injection is a selective internal radiotherapy product for liver malignancies. It utilizes leading interventional technology to deliver Y90 resin microspheres into the liver tumor vasculature, releasing high-energy beta radiation to destroy tumor cells, combining the dual advantages of radiopharmaceuticals and precision interventional therapy.
In fact, the Y90 microsphere injection is already a mature, blockbuster product validated by long-term market use and clinical experience. Having been on the market for over two decades, it has been used in more than 50 countries and regions, with cumulative administrations exceeding 150,000. Its efficacy and safety are widely recognized by physicians and patients globally, and it is recommended in treatment guidelines from several international authoritative bodies, including the US National Comprehensive Cancer Network (NCCN), as well as Chinese clinical practice guidelines such as the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2026 Edition)." In the domestic Chinese market, YIGANTAI® has demonstrated substantial commercial strength, driving nearly a 15-fold increase in revenue for GRAND PHARMA's nuclear medicine oncology division over four years. Leveraging the company's overseas autonomous sales network and bolstered by this strong clinical data, future overseas sales of the Y90 microsphere injection are expected to increase further.
The DOORwaY90 trial is the first pivotal, prospective, multicenter clinical study in the US to utilize partition dosimetry technology for administering Y90 selective internal radiotherapy (SIRT) to patients with unresectable HCC. The study data show that the trial successfully met its pre-specified co-primary endpoints with remarkable results. As assessed by blinded independent central review, the complete response (CR) rate reached 90%, and the best overall response rate (ORR) was 99%. All evaluable patients responded to treatment, achieving a local tumor control rate of 100%, representing one of the highest response efficacies reported to date for Y90 therapy. Additionally, the Y90 microsphere injection demonstrated durable efficacy, with 75% of patients having a duration of response exceeding 6 months and a median duration of response reaching 295 days. Over 95% of patients maintained stable liver function at the 12-month mark.
The excellent clinical data indicate that the Y90 microsphere injection can achieve tumor response without compromising liver reserve function, potentially reshaping the HCC treatment landscape and offering patients longer survival and higher quality of life. Furthermore, the personalized dosimetry treatment model not only outperforms traditional treatment options but also broadens the application scope of liver-directed therapy for patients with unresectable HCC, providing a more precise treatment approach. The successful achievement of the clinical trial endpoints will strongly support the further expansion of the Y90 microsphere injection's indication range, directly contributing to a strategic enlargement of its market potential.
Liver cancer is the sixth most commonly diagnosed cancer and the third leading cause of cancer death worldwide. According to GLOBOCAN 2022 data, there are approximately 870,000 new cases and 760,000 deaths from liver cancer globally each year. China's National Cancer Center's 2024 national cancer report indicated about 370,000 new liver cancer cases in China in 2022 (accounting for 42.5% of the global total), ranking fourth among cancers, and approximately 320,000 deaths (42.1% of global deaths), ranking second; both proportions are the highest globally. Among all liver cancer types, hepatocellular carcinoma (HCC) is the most common, comprising 85%–90% of cases. However, early-stage liver cancer symptoms are often subtle, making timely detection difficult, resulting in fewer than 30% of patients being eligible for curative surgery upon initial diagnosis. Even after surgical resection, the five-year postoperative recurrence and metastasis rate remains high, at 50%–70%. In terms of survival outcomes, the five-year survival rate for liver cancer patients in China is only 12%, indicating a significant unmet clinical need.
Data suggests the global market size for liver cancer therapeutics is projected to reach approximately $9.81 billion by 2030. Additionally, the market space for HCC drugs in China is expected to reach about RMB 48.7 billion by 2030, representing a considerable market opportunity. The outstanding clinical performance of the Y90 microsphere injection provides an effective, accessible, and better-tolerated treatment option for patients with intermediate and advanced liver cancer. With the success of this US clinical trial, the product's global commercial expansion will receive stronger data support. In the future, it is expected not only to benefit domestic patients more rapidly and broadly, helping to improve China's overall liver cancer diagnosis and treatment standards, but also to provide a superior treatment choice for patients worldwide, further driving the high-speed growth of GRAND PHARMA's nuclear medicine segment.
The successful achievement of endpoints in the pivotal US clinical trial for the Y90 microsphere injection not only further validates the product's exceptional efficacy but also highlights GRAND PHARMA's robust overseas R&D and registration capabilities. In the nuclear medicine field, the company has established a fully integrated global system covering R&D, production, logistics, and sales, based on R&D centers in Boston and Chengdu, production bases in Boston, Frankfurt, Singapore, and Chengdu, and an autonomous sales network covering over 50 countries and regions. The company possesses strong independent R&D, registration, and commercialization capabilities overseas, positioning it as a leader in the global nuclear medicine oncology sector.
Regarding its product pipeline, GRAND PHARMA adheres to a "diagnosis-and-treatment integration" development philosophy, building a multi-level, high-quality innovation matrix. The company currently has 16 innovative nuclear medicine products in the R&D/registration phase, involving five key radionuclides (68Ga, 177Lu, 131I, 90Y, 89Zr) and covering seven major cancer types, including liver cancer, prostate cancer, kidney cancer, and brain cancer. Additionally, it has over 10 candidates in early-stage R&D, forming a favorable pattern of diagnostic and therapeutic synergy with multi-indication coverage. Presently, six innovative radiopharmaceutical drug conjugates (RDCs) from the company have entered registered clinical studies, with one in the New Drug Application (NDA) stage and three in Phase III clinical trials, indicating significant potential in the innovative nuclear medicine pipeline.
In recent years, GRAND PHARMA's nuclear medicine segment has seen consecutive milestone breakthroughs for its core products and key pipeline assets. The company's self-developed, globally innovative small molecule RDC drug GPN01530, which targets fibroblast activation protein (FAP), received FDA approval to initiate Phase I/II clinical trials, marking the company's first self-developed RDC product to gain FDA clinical approval. This approval also provides an important model for the international development of the company's nuclear medicine pipeline and showcases the excellent preclinical development and international registration capabilities of GRAND PHARMA's nuclear medicine technology platform. Furthermore, an investigator-initiated trial (IIT) for GPN02006 in China achieved a milestone breakthrough and was selected for an oral presentation at the 2025 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in North America. GPN02006 has the potential to become the world's first GPC-3-targeted diagnostic RDC product for HCC, continuously demonstrating the company's global innovation strength.
In terms of industrial infrastructure, the company has achieved comprehensive self-sufficiency and control in its nuclear medicine industry. In June 2025, GRAND PHARMA's Wenjiang Radiopharmaceutical R&D and Production Base in Chengdu officially commenced operations, representing the world's first fully closed-loop nuclear medicine industrial chain platform. This base features 14 high-standard GMP production lines, enabling full-chain self-sufficiency from isotope preparation and R&D to production, clinical application, and commercialization, thereby resolving potential supply chain bottlenecks in key nuclear medicine processes. It is one of the world's most comprehensive nuclear medicine facilities in terms of radionuclide variety and automation level, providing solid support for the rapid industrialization of the company's global innovations.
The successful achievement of endpoints in the overseas clinical trial for the Y90 microsphere injection marks a significant milestone in GRAND PHARMA's "Go Global" strategy, further underscoring the company's strong international R&D capabilities and the immense potential of its nuclear medicine platform. Looking ahead, GRAND PHARMA is poised to continue strengthening its global competitive advantage in the nuclear medicine field, accelerating the development and translation of more innovative nuclear medicines to contribute to overcoming various malignancies, improving patient quality of life, and consolidating its leading position in the global nuclear medicine arena.
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